One
out of every two Americans will likely be stricken with some form of
cancer. FDA approved cancer treatments are ordinarily not curative.
Those treatments, consisting principally of radiation and chemotherapy,
offer little hope and much misery for the vast majority of cancer patients.
The FDA approved treatments rarely result in longevity greater than
if the patient received no treatment at all, yet access to unapproved,
experimental treatments depends on FDA allowance. While FDA allows access
to experimental drugs sponsored by favored regulatees (large drug companies
with a long history of agency drug approvals), it often denies access
to experimental drugs sponsored by innovative companies that lack a
cozy relationship with the agency. FDA’s control of access is
rife with conflict of interest, bias, arbitrariness, and subjective
discrimination. Assuming near Godlike power, FDA ultimately determines
who may have access to unapproved cancer treatments that hold out hope
for a cure and who may not.

A
recent brilliant documentary by Nehst Out entitled Cut Poison Burn (available
at cutpoisonburn.com) reveals the desperate and horrible circumstances
befalling those who must not only struggle to fight cancer afflicting
their loved ones but also a Food and Drug Administration that denies
them access to their treatment of choice and condemns them to FDA approved
therapies that even their conventional oncologists have deemed incapable
of arresting the cancer’s progression. The documentary focuses
on the Navarro family’s struggle to save a beautiful young boy,
Thomas Navarro, from the ravages of glioblastoma (an aggressive brain
tumor). As if the torture endured through rounds of chemotherapy and
radiation were not enough, the Navarros must also struggle with an FDA
that in their most urgent hour denies them access to a promising experimental
cancer treatment and consigns Thomas to a horrible death.

Despite
its abysmal track record since President Nixon declared war on cancer
in 1971, conventional cancer treatment has become very big business.
In 2010, cancer care cost the American public an estimated $125 billion,
yet even with expenditures of that enormous size almost all have died
either from the treatments administered or from cancer progression,
or both. The ugly truth is that the federal government has lost the
war on cancer yet compels Americans to purchase the same failed treatments
for the disease by locking out promising experimental alternatives.
FDA jealously guards the interests of the largest drug manufacturers,
commonly allowing access to clinical trials of their cancer drugs, while
disallowing access to clinical trials sponsored by individuals and companies
that lack a cozy relationship with agency regulators. The consequence
is a horrific destruction of innovation in medicine and of hope for
terminally ill cancer patients. Federal law allows FDA regulators to
possess the power to determine the fate of the terminally ill, yet those
regulators have an inherent conflict of interest that influences their
decisions. If they leave government service, they will do well financially
if they secure positions of employment with major drug companies, but
they will limit prospects for such employment if they offend those regulatees
by allowing competing innovators to expand treatment uses of experimental
cancer drugs.

Because
half the American population is bound to contract cancer and most cancers
are incurable, a just government would do everything in its power to
ensure that those diagnosed with cancer would be informed of and encourage
to explore alternatives, provided they were informed of the potential
risks and known benefits of each option as compared to the FDA approved
treatment. That is not the case, however. For those seeking an alternative
to FDA approved treatment and to FDA favored drug manufacturers, the
agency has an all too common answer: No (and often “no”
without any rational explanation).

FDA
jealously guards its gate-keeper role, whereby drugs are only allowed
to be marketed if they have been given FDA approval. The system is one
FDA Associate Director of the Office of Drug Safety David Graham has
described as corrupt, favoring incumbent drug company regulatees even
to the extent of approving unsafe drugs like Vioxx and Avandia. Economists
schooled in public choice theory regard FDA as a quintessential example
of industry capture (whereby the regulators become servants of the agency’s
principal regulatees). FDA argues that it must paternalistically police
who has access to experimental drugs because to do otherwise would permit
unapproved cancer therapies that may be harmful to proliferate, making
a mockery of the agency’s costly drug approval process. Companies
and individuals would avoid the expense and burden of seeking FDA approval
for drugs, the agency contends, choosing instead to make the unapproved
drugs available to large segments of the population without seeking
agency approval.

That
argument is quite fickle, and it rests on a series of false assumptions.
At the outset, because FDA approves or disapproves clinical trials,
the universe of trials is limited to those trials which the FDA believes
hold out some promise of efficacy. In addition, the number of people
who are terminally ill with cancer for whom conventional treatments
are inefficacious is a set figure and involves people for whom FDA has
failed (in other words, despite their dire need there is no FDA approved
treatment capable of curing their terminal illnesses). Demand for cancer
treatment at any particular moment is inelastic and, so, the notion
that an unlimited expansion in patient sales would occur in the market
is fictive. Moreover, when conventional treatments are inefficacious,
hope for life depends entirely on access to experimental drugs which,
by definition, are not FDA approved, regardless of who sponsors them.
Finally, in practice FDA does not deny cancer patients access to experimental
drugs in toto, regardless of the sponsor. Rather, FDA acts selectively,
granting access based on the exercise of subjective, politically influenced
opinion. The very same patient denied access to a clinical trial whose
sponsor is disfavored by FDA can be admitted to a clinical trial for
a different drug by a sponsor favored by the agency.

The
system for allowing access is corrupt, heavily subject to political
influence, and biased in favor of drug company sponsors favored by the
FDA, namely those that have a cozy relationship with the FDA from years
of seeking and obtaining approval of drugs. Congressmen Dan Burton and
Peter DeFazio know well the corruption within the agency. Each has confronted
FDA Commissioners who condemned without recourse patients seeking access
to experimental drugs by sponsors disfavored by the agency. Each has
demanded reversals of those decisions and in several instances (despite
FDA asserting to sponsors and patients that the decisions were medically
based and final), the Commissioners have ordered reversals bowing to
political pressure, sometimes too late for the patients concerned.

When
a patient seeks an experimental drug for a serious or life-threatening
condition, an ordeal of extraordinary proportions may confront the person
when he or she is least able, physically and emotionally, to endure
it. The drug trial sponsor must be contacted and convinced to seek a
“compassionate use” exemption from the FDA. That request
for exemption comes in the form of either a “single patient investigational
new drug” submission by the sponsor or, if the patient may die
imminently, an “emergency investigational new drug” submission
(which may be made by phone). FDA political appointees exercise enormous
subjective discretion in determining if a patient with cancer will be
permitted to have access to a clinical trial of an experimental cancer
drug. FDA ordinarily allows afflicted patients access to an experimental
drug, provided that it is recommended by a physician and is acceptable
to the drug company sponsor. In a significant number of cases, however,
the FDA refuses access to a clinical trial. Although the agency is loath
to admit it, denial of the patient’s choice occurs in those instances
where the FDA harbors a bias against the sponsor or the treatment. Sometimes
that bias is born of good evidence that the clinical trial is fraudulent
or that the experimental drug is too dangerous, but it may also be born
of an agency effort to ensure that favored regulatees are protected
against new or novel cancer treatments of promise from an individual
or company not among those having close ties to the agency.

The
decision to deny a dying patient access to an experimental drug is an
extraordinary exercise of federal power. That horrific decision is made
daily by the directors of FDA’s Division of Oncology Products
(Drs. Robert Justice and Patricia Keegan) under the direct supervision
of the FDA Commissioner Margaret Hamburg. The FDA has criteria in 21
C.F.R. § 312.305 that limit access, but it exercises considerable
discretion in interpreting the criteria, resulting in inconsistent decision
making. Repeatedly members of Congress, most notably Congressman Dan
Burton from Indiana and Congressman Peter DeFazio from Oregon, have
pressured FDA Commissioners to reverse decisions denying access that
the Oncology Products Division Directors declared final. While FDA Commissioners
protest that their decisions are wholly science based, in fact the subjective
criteria and the inconsistencies in decision prove that bias is the
norm and that those with political access to the powerful can achieve
reversals.

When
determining if a patient will be given access to a clinical trial, FDA
considers a few subjective factors. First, it requires that the patient
have a “serious or immediately life-threatening disease”
that is essentially not treatable with FDA approved drugs and devices.
In 21 C.F.R. § 312.300(b), FDA reveals the inherent subjectivity
in this determination: “Whether a disease or condition is serious
is a matter of clinical judgment, based on its impact on such key factors
as survival, day-to-day functioning, or the likelihood that the disease,
if left untreated, will progress from a less severe condition to a more
serious one.” Next, FDA evaluates the treatment, again on largely
subjective grounds, assessing whether “[t]he potential patient
benefit justifies the potential risks of the treatment use and those
potential risks are not unreasonable in the context of the disease or
condition to be treated.” FDA then insinuates its anti-competitive
bias into the process, deeming even a drug for which clinicians recommend
access for the terminally ill be kept from those patients on the basis
that allowing the use would “interfere with” potential FDA
market approval for the drug or because FDA deems other drugs under
another IND or FDA approved drug protocol available for treatment use.

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When
the drug sponsor is a large pharmaceutical company having a portfolio
of several FDA approved drugs seeks a compassionate use exemption, it
is ordinarily granted. The subjective factors are all resolved in the
sponsor’s favor. When the drug sponsor lacks that cozy relationship,
FDA often subjectively concludes the treatment to be one with potential
risks that are unreasonable or concludes the condition to be one for
which FDA approved treatments remain available. It is, of course, always
the case that an FDA approved treatment is available for cancer or that
another IND by a favored regulatee is available for treatment use. The
factor is thus entirely fungible, depending on the political preference
of the regulator. Chemotherapy, radiation, and surgery are conventionally
approved to one extent or another for every cancer. So FDA may always
conclude that an experimental treatment is unwarranted because the patient
could receive treatments that are FDA approved instead or could participate
in some other IND for the cancer.

The
FDA’s political manipulation of the compassionate use process
is one of the greatest examples of arbitrary and capricious agency action.
It carries with it consequences acceptable to no one but the FDA bureaucrats
who administer the program: destruction of patient hope and life. When
a director of the Division of Oncology Products decides to deny a terminally
ill patient access to an experimental treatment, that interposition
of federal power between doctor and patient has profound consequences.
Invariably the patient’s last, best hope for cure is removed by
force of law, compelling the patient either to leave the country in
search of the same or comparable treatments, return to horrific chemotherapy
and radiation treatments that will make life unbearable and may hasten
death, or resign to die.

On
June 17, 2011, Patricia Clarkson was diagnosed with Stage III multiple
myeloma. Although predicting an individual’s life expectancy is
in fact impossible, Patricia’s doctor, like many oncologists and
hematologists, make those unscientific predictions. Her doctor told
her that she had no more than 4 to 5 years of life left. This common
practice is not only unscientific but also cruel in the extreme and
contrary to medical ethics because it inflicts injury, often causing
the patient diagnosed with cancer to experience a profound loss of hope
and a feeling of utter helplessness, conditioning them to accept with
resignation whatever treatment regimen is recommended even treatments
with lethal side effects. Often patients diagnosed with cancer and given
an estimate of time left suffer a loss of the will to live and a diminution
in their immune system that hastens death.

Patricia
underwent a battery of tests, two MRIs, bone scans, and sophisticated
laboratory analyses, all confirming the diagnosis of Stage III multiple
myeloma. On June 18, 2011, she was hospitalized for sudden acute kidney
failure, but she responded well to treatment and was released on June
21. While hospitalized, she was placed on Velcade, a chemotheraphy drug.
The Velcade reduced her plasma tumors from 80% to 15%, but she began
to experience gastroenterological reactions to the drug and severe pain
in her lower back.

She
was then given radiation therapy. Her reactions to the Velcade became
so severe that her treatment regimen was halted, pending resolution
of the reactions. In the interim, one of her oncologists advised that
genetic testing revealed that she was missing chromosome 13 and gene
p53 (a condition common among 50% of those afflicted with multiple myeloma),
which he said would reduce her life expectancy to a year or two. Again,
this heartless, unscientific pronouncement only further injured Patricia’s
psyche atop the enormous physical suffering she had already experienced.

This
oncologist recommended a bone marrow transplant which he said would
extend her life one to two years (another unscientific prediction because
bone marrow transplants in these circumstances are notoriously unsuccessful).
Fortunately Patricia did her own research on bone marrow transplantation
and decided that the length of hospital stay, risk of complications,
and likely need for more than one transplantation surgery made it a
foolish option.

In
late November 2011, convinced that there was no conventional option
that offered her any hope and that each option given her would come
with greater physical disability and pain, decreasing, not increasing,
her life expectancy, Patricia began looking for non-conventional alternatives.
Having discussed the matter with trusted friends, she became convinced
that she might benefit from receiving antineoplastons, a non-toxic,
experimental drug discovered over thirty years ago by medical researcher
Dr. Stanislaus Burzynski. One of those friends, Mary Jo Siegel, was
diagnosed twenty years before with non-Hodgkins lymphoma and was pronounced
cured following receipt of the antineoplastons treatment. Patricia traveled
to Houston to meet Dr. Burzynski. Dr. Burzynski regretfully informed
Patricia that the FDA had ruled that it would not grant any additional
compassionate use exemptions for patients to receive his antineoplatons,
although FDA had approved numerous exemptions in 2011. After conducting
a physical exam and evaluating the test results, Dr. Burzynski recommended
that Patricia take sodium phenylbutyrate along with the chemotherapy
drug Revlimid until such time as a better option became available. Her
local oncologist acknowledged Patricia’s decision to work with
Dr. Burzynski, but refused to affiliate with him or provide local medical
support, apparently for fear of FDA retaliation against her and her
clinic.

Informed
that the FDA could only be persuaded to lift its ban on Burzynski’s
treatment if enough political pressure were brought to bear, Patricia
contacted her member of Congress, Jerry McNerney. In December McNerney’s
aides sent Erik Laughner, a consumer safety officer in the FDA’s
Division of Oncology Products, a letter requesting a compassionate exemption
for Patricia. The request was denied. FDA offered no explanation for
its denial. Patricia then turned to Senator Diane Feinstein for help.
She wrote to the Senator and asked her to urge FDA to permit participation
in the Burzynski clinical trial. Senator Feinstein’s staff sent
a letter to the FDA on December 14. On January 6, 2012, the FDA responded
with a conclusory denial, reciting that it was aware of no data supporting
“the use of antineoplaston therapy as a potentially safe and effective
treatment for multiple myeloma.”

Patricia
then met with Senator Feinstein’s aides and provided them with
more details supporting her request for access to the Burzynski treatment.
Dan Morrison of Senator Feinstein’s office later informed Patricia
that he did not receive any response to his last inquiry to the FDA.
He had no options to give Patricia other than encouraging her to contact
the FDA directly by phone (a dead end given that FDA refuses to speak
with patients about its compassionate use decisions; it only speaks
to its regulatees, the clinical trial sponsors) or send a letter to
the White House.

The
war on cancer has become a war dominated by “friendly fire,”
where the medical troops fighting the battle more often than not kill
the civilian patients they are supposed to protect. It is a war we have
lost yet continue to wage using the same failed munitions. It is a war
the federal government allows to be waged by those with political influence
but not by those without that influence who nevertheless have discovered
treatments that hold out promise. It is a very corrupt and inhumane
war.

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For
Patricia Clarkson, the need for access to Dr. Burzynski’s antineoplastons
is acute. Because political influence plays such an important part in
this sordid business of convincing the FDA to permit a dying person
freedom of choice, I urge those who read these words to correspond with
the FDA and with their members of Congress to demand that FDA Commissioner
Hamburg act now to reverse FDA’s decision to deny Patricia Clarkson
antineoplastons treatment. You may register your complaint with Commissioner
Margaret Hamburg at the following email address: Margaret.Hamburg@fda.hhs.gov.
You should also ask Congressmen Darrell Issa, Chairman of the House
Committee on Oversight and Government Reform, to demand that Commissioner
Hamburg reverse her the denial of treatment. You can reach him on Twitter
(@DarrellIssa). You should also ask Congressman Dan Burton, member of
the House Committee on Oversight and Government Reform, to intervene
on Patricia’s behalf. You can reach him on Twitter (@RepDanBurton).

Jonathan
W. Emord is an attorney who practices constitutional and administrative
law before the federal courts and agencies. Congressman Ron Paul calls
Jonathan “a hero of the health freedom revolution” and says
“all freedom-loving Americans are in [his] debt . . . for his courtroom
[victories] on behalf of health freedom.” He has defeated the FDA
in federal court a remarkable eight times, six on First Amendment
grounds, and is the author of Amazon bestsellers The
Rise of Tyranny, Global
Censorship of Health Information,
and Restore
the Republic. He is also the American Justice columnist for
U.S.A. Today Magazine. For more info visit Emord.com.

One
out of every two Americans will likely be stricken with some form of cancer.
FDA approved cancer treatments are ordinarily not curative. Those treatments,
consisting principally of radiation and chemotherapy, offer little hope
and much misery for the vast majority of cancer patients.